BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELITE MPX

    MDR report key: 3535824 · Received November 20, 2013

    Report

    Report Number
    1222993-2013-00012
    Event Type
    Other
    Date Received
    November 20, 2013
    Date of Event
    October 29, 2013
    Report Date
    November 15, 2013
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K091169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RECEIVED THE LASER SYSTEM AND RECEIVED TRAINING PER COMPANY POLICY. THEY REPORTED THAT THERE WERE 2 PTS BURNED. ONE ON THE CHIN AND ONE ON THE LEG. SERVICE EVALUATED THE SYSTEM AND DETERMINED THAT IT WAS OPERATING WITH IN SPECIFICATION. THERE WAS NO DEVICE MALFUNCTION. THE OPERATOR BELIEVED SHE USED THE CORRECT TREATMENT PARAMETERS. THEREFORE, THE ROOT CAUSE GOOD NOT BE DETERMINED FOR THE INJURY TO THE CHIN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY BURNED A PT ON THE CHIN AND ON THE LEG. THIS REPORT IS FOR THE CHIN INCIDENT. A SECOND MDR IS BEING FILED FOR THE LEG INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604361 ELITE MPX DERMATOLOGY LASER SYSTEM GEX CYNOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1